Sam Brusco, Associate Editor03.10.21
Able Medical Devices received U.S. FDA 510(k) clearance for its Valkyrie Thoracic Fixation System, which is used for chest wall fracture stabilization, including sternal fixation after sternotomy and sternal reconstructive surgical procedures for patients with normal and/or poor bone.
“The Valkyrie system features the clinically proven performance of rigid fixation combined with the use of novel materials and the benefits of bioactive science to maximize sternal stability and promote bone healing,” Peter J. Didyk, VP and managing director of cardiothoracic and an inventor of the Valkyrie system told the press. “Its patient-specific design offers intraoperative choices, and its minimal instrumentation focuses on speed, efficiency, and simplicity in the O.R., making it a highly desirable product on the market.”
The PEEK-based system can easily be cut during emergent re-entry, prevents post-op image scatter, and conforms to meet various patient anatomies. The double lead screws insert into the bone more quickly and increase bone purchase, while their HAnano surface treatment recruits cellular adhesion and quickly synthesizes bone to create more rigid closure.
“Surgeons may choose from an array of various implant shapes and sizes, but after a long case, the simplicity of the system removes much of the guesswork which is greatly preferred,” said Steven J. Hicks, CEO and president of parent company J.M. Longyear. “This sterile-packaged, single instrument system offers a wide variety of benefits while its bioactive screws and contourable plates set an industry standard in sternal closure.”
“The Valkyrie system features the clinically proven performance of rigid fixation combined with the use of novel materials and the benefits of bioactive science to maximize sternal stability and promote bone healing,” Peter J. Didyk, VP and managing director of cardiothoracic and an inventor of the Valkyrie system told the press. “Its patient-specific design offers intraoperative choices, and its minimal instrumentation focuses on speed, efficiency, and simplicity in the O.R., making it a highly desirable product on the market.”
The PEEK-based system can easily be cut during emergent re-entry, prevents post-op image scatter, and conforms to meet various patient anatomies. The double lead screws insert into the bone more quickly and increase bone purchase, while their HAnano surface treatment recruits cellular adhesion and quickly synthesizes bone to create more rigid closure.
“Surgeons may choose from an array of various implant shapes and sizes, but after a long case, the simplicity of the system removes much of the guesswork which is greatly preferred,” said Steven J. Hicks, CEO and president of parent company J.M. Longyear. “This sterile-packaged, single instrument system offers a wide variety of benefits while its bioactive screws and contourable plates set an industry standard in sternal closure.”